MedDataX Logo

Head & Neck Cancer Survivorship: Physical and Functional Status

NCT ID: NCT00751816

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Early physical therapy may be effective in improving range of motion of the neck and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation therapy.

PURPOSE: This phase I trial is studying how well early physical therapy works in improving physical and functional well-being in head and neck cancer survivors receiving chemoradiotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* Describe the physical and functional well-being of head and neck cancer (HNC) survivors undergoing physical therapy during adjuvant chemoradiotherapy.
* Describe clinical measure of range of motion for the cervical spine and shoulder of HNC survivors undergoing physical therapy during adjuvant chemoradiotherapy.
* Determine the feasibility of an early physical therapy intervention (prior to and during adjuvant treatment) targeting the physical needs of HNC survivors.

OUTLINE: Patients undergo physical therapy weekly for 10 weeks beginning 1 week prior to initiating adjuvant chemoradiotherapy and continuing until 2 weeks after the completion of adjuvant chemoradiotherapy.

Patients undergo range of motion assessment and complete a Cancer Survivorship Survey (CSS) at baseline and in weeks 4, 8, 9, and 10 of physical therapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

musculoskeletal complications stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx stage I adenoid cystic carcinoma of the oral cavity stage I mucoepidermoid carcinoma of the oral cavity stage I verrucous carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage II mucoepidermoid carcinoma of the oral cavity stage II verrucous carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I basal cell carcinoma of the lip stage II basal cell carcinoma of the lip stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip stage I lymphoepithelioma of the nasopharynx stage I squamous cell carcinoma of the nasopharynx stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage I lymphoepithelioma of the oropharynx stage I squamous cell carcinoma of the oropharynx stage II lymphoepithelioma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III lymphoepithelioma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity stage I inverted papilloma of the paranasal sinus and nasal cavity stage I midline lethal granuloma of the paranasal sinus and nasal cavity stage I squamous cell carcinoma of the paranasal sinus and nasal cavity stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity stage II inverted papilloma of the paranasal sinus and nasal cavity stage II midline lethal granuloma of the paranasal sinus and nasal cavity stage II squamous cell carcinoma of the paranasal sinus and nasal cavity stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity stage III inverted papilloma of the paranasal sinus and nasal cavity stage III midline lethal granuloma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity stage IV inverted papilloma of the paranasal sinus and nasal cavity stage IV midline lethal granuloma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity high-grade salivary gland mucoepidermoid carcinoma low-grade salivary gland mucoepidermoid carcinoma salivary gland acinic cell tumor salivary gland adenocarcinoma salivary gland adenoid cystic carcinoma salivary gland anaplastic carcinoma salivary gland malignant mixed cell type tumor salivary gland poorly differentiated carcinoma salivary gland squamous cell carcinoma stage I salivary gland cancer stage II salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

systemic chemotherapy

Intervention Type DRUG

survey administration

Intervention Type OTHER

will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.

adjuvant therapy

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

musculoskeletal complications management/prevention

Intervention Type PROCEDURE

physical therapy

Intervention Type PROCEDURE

weekly visits coordinated with adjuvant treatment as part of standard care

radiation therapy

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

systemic chemotherapy

Intervention Type DRUG

survey administration

will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.

Intervention Type OTHER

adjuvant therapy

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

musculoskeletal complications management/prevention

Intervention Type PROCEDURE

physical therapy

weekly visits coordinated with adjuvant treatment as part of standard care

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

none noted none noted none noted None noted none noted none noted none noted

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Head and neck cancer survivor
* Planning to receive adjuvant chemoradiotherapy for head and neck cancer

* Has not yet initiated adjuvant therapy
* Referred to rehabilitation oncology physical therapy program

Exclusion Criteria

* No metastatic disease
* No CNS cancer

PATIENT CHARACTERISTICS:

* Speaks English
* No significant history of cardiovascular or neurovascular disease involving disability

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Not currently in hospice care
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann Marie Flores, Ph.D.

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VU-VICC-SUPP-0843

Identifier Type: -

Identifier Source: secondary_id

CDR0000613863

Identifier Type: -

Identifier Source: org_study_id